March 4, 2003
Co-existence of Genetically
Modified, Conventional and Organic Crops
Communication from Mr Fischler to the Commission of the European
Community
1. Background / political
context
The issue of co-existence
concerns the economic consequences of adventitious presence of
genetically modified (GM) crops in non-GM crops. The issue has
its origin in the principle that farmers should be able to
cultivate freely the agricultural crops they choose, be it GM
crops, conventional or organic crops. No form of agriculture
should be excluded in the EU.
Much of the policy debate
surrounding the introduction of GMOs in the EU has centred on
concerns about potential risks to human health and the
environment and on the right of consumers to choose between GM
and non-GM products. The regulatory framework that has been
developed responds to these concerns. Authorisations ofGMOs are
subject to a stringent risk assessment in respect of risks for
human health or the environment. The rules on labelling and
traceability will facilitate consumer choice.
However, the cultivation of GMOs
in the EU will '~lso have an impact on agricultural production.
In particular, it raises the question of how to manage the
adventitious admixture of GM and non-GM crops, resulting from
seed impurities, cross-pollination, volunteers (self-sown
plants, mainly from harvest fall-out carried over to the next
growing season), harvesting-storage practices anq transport, as
well as its possible economic consequences. The ability of the
agricultural sector to deliver a high degree of consumer choice
is linked to its ability to maintain different production
systems.
Against this background, the
Commissi'on has committed itself to:
"...take the initiative to
develop, in partnership with Member States, farmers and other
private operators, research and pilot projects to clarify the
need, and possible options, for agronomic and other measures to
ensure the viability of conventional and organic farming and
their sustainable co-existence with genetically modified crops".
[Action 17 of the
Communication on "Life Sciences and Biotechnology - A Strategy
for Europe"]
The issue of co-existence has
been raised on several occasions in Council and Parliament.
Member States are now also focusing on this issue. A Danish
report on co-existence has recently been discussed by the
national Parliam~nt, and a Swedish report will be finalised this
spring. The UK government is awaiting the results of large-scale
field experiments on the use of GM crops before taking any
further steps regarding the use of GMOs in agriculture. Other
Member States have also been studying measures to establish
co-existence, including the possibility of creating GMO-free
zones.
There are growing concerns that
any perceived or actual problems related to co-existence could
make Member States more hesitant to grant new authorisation for
GMOs in agriculture.
2. The concept of co-existence
The issue of co-existence of
different production systems is closely linked to the
introduction of legal thresholds for the adventitious presence
of authorised GM crops in non-GM crops. The current
food-labelling threshold is 1 %, whilst the Council agreement on
the GM Food and Feed proposal establishes a 0.9 % threshold for
food and feed. For seeds, the Commission is preparing a proposal
establishing three different thresholds (0.3 %, 0.5% and 0.7%,
according to the crop) for the presence of GMOs in conventional
seed lots.
Adventitious presence above the
threshold triggers the need for the crop to be labelled. It is
assumed that this situation could cause a loss of income or
difficulties in selling the crop. Coexistence is, therefore,
concerned with the potential economic impact of the admixture of
GM and non-GM crops at farm level, and with management measures
to minimise admixture.
The most cited example of income
loss is that of conventional and organic farmers who have to
sell their crop at a lower price because of the adventitious
presence of GM crops above the authorised threshold level.
Whilst for conventional farming the policy is clear, and the
possibility of economic damage is linked to the level of the GMO
labelling thresholds, for organic farming the situation still
has to be clarified. The organic farming regulation establishes
that no GMO shall be used in production, but is not specific
concerning the question of gene flow from GM crops into organic
crops. The regulation does allow for the
setting of a threshold for the
adventitious presence of GMOs in organic products, but no
threshold has been set. So far, in the regulatory Committee,
Member States have been
reluctant to establish such a threshold at
Community level.
There is also, however, the
opposite example, where a speciality GM crop could depreciate in
value because of admixture with non-GM crops.
It is important to make a clear
distinction between the economic aspects and the environmental
and health aspects dealt" with under Directive 200l/l8/EC on the
deliberate release of GMOs into the environment.
According to the
procedure laid down in Directive 200l/l8/EC, the authorisation
to release GMOs into the environment is subject to a
comprehensive health and environmental risk assessment. The
outcome of the risk assessment can be one of the following:
-
a risk of an
adverse effect to the environment or health' that cannot be
managed is identified, in which case authorisation is refused;
-
no risk of
adverse effects on the environment or health is identified, in
which case authorisation is granted without requiring any risk
management measures;
-
risks are
identified, but they can be managed with appropriate measures
(e.g., physical separation and/or monitoring); in this case
the authorisation will carry the obligation to implement
environmental risk management measures;
-
a risk to
the environment or health is identified after the
authorisation has been granted, in which case a procedure for
the withdrawal of the authorisation or for modifying the
conditions of consent according to Article 20 of the Directive
is initiated under the safeguard clause set out in Article 23
of the Directive.
No further justification exists
for Member States to prohibit, restrict or impede the placing on
the market of authorised GMOs.
Since only authorised GMOs can be cultivated in
the EU and the environmental and health aspects are covered by
Directive 2001/18/EC, the objective and the management issue to
be addressed in the context of co-existence concern exclusively
the economic aspects associated
with adventitious presence of GMOs and the
feasibility and the costs of measures to reduce the admixture of
GM and non-GM crops.
The application of such measures
is not a new issue in agriculture. Seed producers, for example,
have a great deal of experience of implementing farm management
practices to ensure seed purity standards.
3. Preparatory work carried
out on the co-existence issue
In order to prepare the ground
for the development of policy options, the Commission
services have engaged in a
thorough examination of the various aspects of co-existence. The
focus has been on
collecting, assessing and expanding the scientific evidence in
this area, in particular as regards the economic consequences of
the adventitious presence of authorised GMOs in non-GM crops and
the potential farm management measures to reduce this presence.
A study on co-existence conducted
by the Joint Research Centre was published last year. This
contains model-based results on the spreading of authonsed GMOs
and possible management measures for addressing the economic
consequences.
In addition, the Joint Research Centre has
recently made a brief up-to-date summary of the
scientific evidence as regards
co-existence, based on its own work and other available studies,
as well as national co-existenc\;: schemes that are currently
being developed.
In 2001, the Scientific Committee
on Plants (SCP) delivered an opinion on the probability of the
adventitious presence of authorised GM seeds in conventional
seed lots, which summarised the scientific information available
at the time. In January 2003, the SCP stated that there is no
significant scientific evidence to give reasons for the need to
up-date its opinion from 2001.
One of the results is that
appropriate and crop specific management practices are key to
addressing the issue of co-existence and to ensuring that
threshold levels are not exceeded. At the same time, the SCP
concluded that a zero level of adventitious presence is
unobtainable in practice.
The JRC study and a recent report
on co-existence from a Danish expert group confirmed that the
probability of admixture, as well as measures for reducing it,
are highly crop-specific. The banish study also suggests that
under conditions of a limited GMO share (10%) and a general'
threshold of 1 % for adventitious presence of GM crops in non-GM
crops, co-existence can be ensured for most crops in Denmark
(i.e., beet, maize, potatoes, barley, wheat, oats, triticale,
rye, lupine, broad beans and peas). For some crops current
farming practices may need to be modified, whereas in other
cases difficulties with co-existence are virtually non-existent
under these conditions. However, for oilseed rape, as well as
for seed production of certain crops, ensuring co-existence may
be more problematic and further evaluation is required, before
guidelines can be developed.
It is also clear that
location-specific differences in natural conditions, production
patterns, farm structures and field sizes will to a large extent
determine what are efficient and costeffective measures for
ensuring the co-existence of different production systems.
Farm management measures
The choice of measures
will depend on the specific characteristics of the plant
or seed variety in question, as well as the environment
in which it is grown. Examples of possible agronomic and
farm management measures are:
buffer zones
pollen barriers
control of volunteers
crop rotation and planting arrangements
for differing flowering periods
monitoring during
cultivation, harvest, storage, transport and
processing.
Most of these management
measures apply to individual farmers. Given that the aim
of the measures remains purely economic, the burden of
applying measures to deal with coexistence should fall
on the economic operators (farmers, seed suppliers,
etc.) who intend to gain a benefit from the specific
cultivation model they have chosen.
Some measure,s are more
efficient if coordinated among neighbouring farmers
(e.g. complementary crop rotation). In addition, certain
management practices, such as planting arrangements for
different' flowering times or region-wide border
management, actually require cooperation between
neighbouring farms.
Although these measures still need to be defined more
precisely, it is likely that the interdependence between
neighbouring farmers needs to be taken into account in
the search for cost-effective solutions.
The introduction of
binding rules on farm management measures would, in such
cases, make it necessary to decide not only on how to
distribute the burden of these measures between the
different types of production systems, but also how, and
to what extent, public authorities could or should
intervene in the relationship between farmers. |
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In summary, scientific
information for launching a constructive policy debate on the
economic consequences of adventitious presence of GMOs is
already available. However, it must be noted that there are
still important issues that will benefit from further study.
This concerns in particular the costs of implementing
"best-practice" measures, which will influence the costs of
establishing separate GM and non-GM production lines and which
will' also have a bearing on the competitiveness ofEU
agriculture.
Another area where little is
known is the magnitude of the potential economic loss due to the
adventitious presence of GM crops in non-GM crops. This question
is related to the price premium that one class of products might
command over the other in the future.
It should also not be forgotten
that much of the data on gene flow and management measures are
based on research models and expert opinion, and are not yet
sufficiently validated by field experience. More data from
large-scale field trials, and indeed from the few regions in the
EU where GMOs are actually' grown, would be useful in this
respect.
An encouraging trend is that an
increasing number of initiatives are being taken by the Member
States. In the UK, a code of good practice for
herbicide-resistant crops is currently being tested under field
conditions. In Denmark, possible farm management practices
adapted to the national situation are being discussed. Member
States are already playing an important role in developing
measures for safeguarding co-existence.
In this context, it should be
clear that the European Institutions, Member States and
stakeholders must work together to find practical, proportionate
and cost-effective solutions that are in the interest of all
parties. To facilitate this process, the Commission will
organise a Round Table on research results relating to
co-existence as an opportunity for experts, stakeholders, and
Member State representatives to discuss and exchange relevant
information and experiences. The Round Table is scheduled on 24
April 2003.
The Commission will also pursue
its efforts to increase the knowledge in this area. In addition
to organising a Round Table on co-existence with experts and
stakeholders, it will launch a follow-up of the study on
"Scenarios for co-existence of genetically modified,
conventional and organic crops in European agriculture", to be
carried out by the Joint Research Centre.
Future studies on co-existence,
combining the various aspects of co-existence, as well as
environmental and other aspects related to the introduction of
GMOs, will also be carried out under the 6th Community Research
Framework Programme, in particular under the thematic priorities
5 (Food quality and safety) and/or 6 (Sustainable development,
global change and ecosystems).
4. The issue of GM-free zones
Certain Member States have
expressed the wish to introduce a ban on the cultivation of GM
crops in certain parts (or all) of the national territory. For
the more problematic crops such GMO-free zones would be an
effective way of reducing GMO spreading to quasi-zero levels
without having to implement further management measures inside
the zones. Border management would, however, still be necessary.
Nonetheless, preliminary legal
assessment suggests that it regulatory measure of this nature,
at either national or Community level, has to be excluded, since
the protection of economic interests alone cannot be invoked as
a legally-valid justification for imposing such strong
limitations on fundamental liberties. In addition, the
establishment of GMO- free zones against the will of some
farmers runs counter to the very principle of co-existence.
Voluntary local arrangements
between farmers or between farmers and industry to ensure the
absence of one or more GM crops in specific areas are, of
course, always possible. Examples of such arrangements already
exist for crops requiring high purity standards or separation,
such as erucic acid oilseed rape.
5. Liability
The question has been raised as
to whether the possibility to seek compensation for economic
loss in the event of gene admixture needs to be regulated on
Community level.
In respect of the principle of
subsidiarity, the first step must be to find out whether the
existing national laws do not already offer sufficient and equal
possibilities in this regard. It may be assumed that most Member
States still apply classic civil law on extra-contractual
liability, where the burden of proof lies with the plaintiff as
concerns the link of causality and the defendant's fault or
negligence.
However, irrespective of whether
liability is regulated on the national or Community level, an
economic loss caused by gene admixture raises the problem of how
to establish the causality link between the action and the
damage. A possible solution would be to provide for a
presumption of fault, whereby the initial burden of proof lies
with the operator who is suspected of not having respected the
obligations imposed on him. Subsequently, the usual general
rules on civil liability would apply to the process of
establishing causality and fault. It is clear, however, that
this approach requires the presence of mandatory management
rules establishing a duty to conform to certain standards and
conduct.
Given the difficulty to establish
the causality link between the action and the damage, another
solution could be to establish, or encourage the establishment,
of collective funds that would be used to cover collective
damages.
The liability issue is,
therefore, closely linked to the policy options dealt with in
this note and will have to be further examined once a policy
approach has been decided.
6. Policy options
The object of any potential
regulatory actions at Community level is agronomic and farm
management measures for the purpose of reducing the economic
consequences that can result from the co-existence of different
farming systems.
Given the fact that there fare
significant crop-specific differences in the economic
consequences as well in the
choice of suitable segregation measures, it is suggested to
focus on those crops
that are most exposed to the risks of admixture and for which an
authorisation for cultivation in the EU is already gr.anted or
pending. For other crops the introduction of GM varieties is
still some years away.
The first priority would be to
address co-existence for GM maize and oil seed rape, as there
are GM events already approved for cultivation in the EU and
further events are pending authorisation under Directive
2001/18/EC.
As far as actions at Community
level are concerned, there are essentially two options:
Option 1: Community action
limited to coordinating: and advisory functions
In the light of the fact that
appropriate measures to address co-existence will vary from one
Member State to another and from one region to another, one
option is to deal with co-existence issues at national level.
This approach would give each Member State the possibility of
defining measures that are tailor-made to its specific
geographical, environmental, and agricultural conditions.
The Commission would limit its
action to the gathering and coordination of information based on
continued studies at Community and national level and observing
the developments in the Member States. This action could be
extended to include offering advice and issuing guidelines,
eventually in the form of a code of good practice.
This approach would allow Member
States to take appropriate measures on the management of the
economic consequences of co-existence, subject to the general
condition that the national measures do not contravene Community
law. In this respect, it would be necessary to ensure that the
Member States respect the limited scope of authority left to
them. The subsidiarity-based approach could be very efficient in
terms of developing farm management measures that are adapted to
local and regional situations.
Advantages:
-
Flexible and
easily adaptable to local and regional conditions, to
developments in science as well as to practical experiences.
-
Can provide
a quick and efficient solution to the most pressing issues,
notably co-existence with regard to maize.
Disadvantages:
-
Country-specific solutions could lead to a certain degree of
regulatory divergence across Member States. However, this need
not necessarily affect the conditions of competition, although
a certain risk in this direction can not be excluded.
-
Need to
confirm that any national actions are proportionate to the
economic risk and that they do not undermine the objectives of
Directive 2O01/18/EC.
Option 2: Lee:islative action
at Community level
The second approach can be
divided into two sub-options, as follows:
a) Adoption of framework
legislation, establishing the basic objectives and principles
applicable to the introduction of management measures for
co-existence. The Community rules would thus b~ limited to
providing a common framework, leaving the Member States with the
task of selecting the measures and regulating their details.
Advantages:
Provides
some flexibility for national solutions within clearly defined
boundaries.
Disadvantages:
-
Need to
confirm that any national actions are proportionate to the
economic risk and that they do not undermine the objectives of
Directive 2OO1/18/EC.
-
Would take
at least a year, or even longer, before adoption.
b) Adoption of legislation that
regulates in detail the requirements to be imposed on farmers
(and other operators) with regard to risk management. The
legislation would have to take account of the various farming
and environmental conditions that prevail in the Member States.
It would also require a thorough cost-benefit assessment of each
specific measure.
Advantages:
Disadvantages:
For both sub-options, the legal
basis for the legislation might be Article 37 of the EC Treaty,
justified by the purpose of managing an economic risk related to
agricultural activities.
7. Final remarks
The Commission has to decide on a
course of action in order to ensure that farmers will be able to
cultivate freely the agricultural crops they prefer, be it GM
crops, conventional or organic crops. The issue of co-existence
concerns only authorised GMOs, and therefore relates solely and
exclusivelyito the economic consequences resulting from the
adventitious admixture of different classes of crops. Risks to
the environment or health are addressed in the GMO authorisation
process under Directive 2001/18/EC.
Any approach to addressing the
issue of co-existence needs to take into account the differences
between crops and crop varieties with respect to their potential
to spread to neighbouring fields. It is, therefore, suggested to
focus on those crops for which GM varieties
have been approved or
are expected to be approved in the near future, and for which
there is a comparatively high probability of admixture.
Appropriate famI management measures are already being developed
in some Member States. There is an indication that their
application would ensure co-existence for a majority of crops
with respect to the currently proposed threshold level. However,
for a few crops, mainly oilseed rape, and to a lesser extent,
maize, measures to ensure co-existence could involve significant
changes in famIing practices.
The fact that the most efficient
and cost-effective measures for ensuring co-existence are likely
to be different from one Member State to another and from one
region to another;' makes an approach based on subsidiarity
appear to be most suitable. This does not, however, mean that
some form of action at Community level to ensure equal
conditions of competition across Member States will not become
necessary at some stage.
Given the importance of the
co-existence issue and the particular attention paid to it by
Member States and stakeholder groups the Commission is
invited to Drovide clear Dolicy directions for the future work
on co-existence.
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